ANTIBACTERIAL SPARKLING MIST- triclosan solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)
Available from:
SAM'S WEST INC
INN (International Name):
TRICLOSAN
Composition:
TRICLOSAN 0.15 mL in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
ANTIBACTERIAL FOR WASHING TO DECREASE BACTERIA ON THE SKIN
Authorization status:
OTC monograph not final
Authorization number:
68196-804-24

ANTIBACTERIAL SPARKLING MIST- triclosan solution

SAM'S WEST INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENT

TRICLOSAN 0.15%

PURPOSE

ANTIBACTERIAL

USE

FOR WASHING TO DECREASE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION AND REDNESS DEVELOP.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON

CONTROL IMMEDIATELY.

DIRECTIONS

SQUEEZE ONTO WET HANDS OR BODY SPONGE, WORK INTO LATHER, WASH SKIN,RINSE

AND DRY THOROUGHLY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE,

GLYCERIN, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10,

COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID,

PROPYLENE GLYCOL, NIACINAMIDE, HIBISCUS, SADARIFFA FLOWER EXTRACT,

TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, CAMELLIA

SINENSIS (GREEN TEA) LEAF EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT

EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, TETRASODIUM

EDTA, SODIUM CHLORIDE, BLUE1, RED 33

ANTIBACTERIAL SPARKLING MIST

triclosan solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 19 6 -8 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRICLO SAN (UNII: 4NM50 39 Y5X) (TRICLOSAN - UNII:4NM50 39 Y5X)

TRICLOSAN

0 .15 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

PEG-8 DIO LEATE (UNII: 6 JR5A7273E)

GLYCERIN (UNII: PDC6 A3C0 OX)

INDELO XAZINE HYDRO CHLO RIDE (UNII: 15QZ6 NE8 4E)

PO LYQ UATERNIUM-10 ( 4 0 0 CPS AT 2 %) (UNII: HB140 1PQFS)

CO CAMIDO PRO PYL PG-DIMO NIUM CHLO RIDE PHO SPHATE (UNII: H2KVQ74JM4)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

NIACINAMIDE (UNII: 25X51I8 RD4)

HIBISCUS SABDARIFFA FLO WER (UNII: 45TGG6 IU6 M)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

ASCO RBYL PALMITATE (UNII: QN8 3US2B0 N)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

EDETATE SO DIUM (UNII: MP1J8 420 LU)

GINGER (UNII: C5529 G5JPQ)

CHAMAEMELUM NO BILE FLO WER (UNII: O2T154T6 OG)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 19 6 -8 0 4-24

720 mL in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 6 /17/20 11

Labeler -

SAM'S WEST INC (051957769)

Registrant -

APOLLO HEALT H AND BEAUT Y CARE (201901209)

Establishment

SAM'S WEST INC

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

APOLLO HEALTH AND BEAUTY CARE

20 19 0 120 9

ma nufa c ture

Revised: 6/2011

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